Kliovance (estradiol, norethisterone)

Kliovance tablets contain two active ingredients, estradiol hemihydrate (previously spelt oestradiol hemihydrate in the UK) and norethisterone acetate. These are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and norethisterone is a synthetic form of progesterone.

What is Kliovance used for?

Second-line option for preventing osteoporosis in postmenopausal women who are at high risk of fractures and cannot take other medicines licensed for preventing osteoporosis.

In December 2003, a review of the available evidence on the risks and benefits of HRT by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM) in the UK, concluded that the risks of using HRT long-term to prevent osteoporosis in women aged over 50 years exceed the benefits. As a result, this medicine should not be used as a first-line option for preventing postmenopausal osteoporosis in women over 50. However, it may be used as a second-line option for women at high risk of fractures who cannot take other medicines that are licensed for preventing osteoporosis.

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Women considered to be at risk of developing fractures following the menopause include those who have had an early menopause, those with a family history of osteoporosis, those who have had recent prolonged corticosteroid therapy (eg prednisolone), those with a small thin frame, and smokers.

You can read more about the risks and benefits of HRT and other medicines for preventing osteoporosis in the factsheets about menopause and osteoporosis linked above.

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How does Kliovance work?

Kliovance tablets contain two active ingredients, estradiol hemihydrate (previously spelt oestradiol hemihydrate in the UK) and norethisterone acetate. These are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and norethisterone is a synthetic form of progesterone.

Womens'' ovaries gradually produce less and less oestrogen in the period up to the menopause, and oestrogen blood levels decline as a result. The declining levels of oestrogen can cause distressing symptoms, such as irregular periods, hot flushes, night sweats, mood swings and vaginal dryness or itching.

Oestrogen (in this case in the form of estradiol) can be given as a supplement to replace the falling levels in the body and help reduce these distressing symptoms of the menopause. This is known as hormone replacement therapy (HRT). HRT is usually only required for short-term relief from menopausal symptoms and its use should be reviewed at least once a year with your doctor.

A progestogen (in this case in the form of norethisterone) is needed as part of HRT for women who have not had a hysterectomy. This is because in women with an intact womb, oestrogen stimulates the growth of the womb lining (endometrium), which can lead to endometrial cancer if the growth is unopposed. A progestogen is given to oppose oestrogen's effect on the womb lining and reduce the risk of cancer, though it does not eliminate this risk entirely. This is known as combined HRT.

Kliovance is a continuous form of combined HRT. Each tablet contains both estradiol and norethisterone, so that a dose of both hormones is taken daily. This type of HRT does not produce a monthly bleed, and so is more suitable for women whose periods have already stopped, eg for postmenopausal women who have not had a period for at least 12 months.

HRT is also sometimes used to prevent osteoporosis in postmenopausal women. The declining level of oestrogen at menopause can affect the bones, causing them to become thinner and more prone to breaking. Oestrogen supplements help prevent bone loss and fractures that may occur in women in the years after menopause.

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How do I take Kliovance tablets?

One Kliovance tablet should be taken once a day on a continuous basis with no breaks between packs. Your need for continued HRT should be reviewed with your doctor at least once a year.

The tablets should be swallowed whole with a drink. They can be taken either with or without food.

Your tablet should be taken at around the same time each day; this will help you remember to take it.

If you forget to take a dose at your usual time and it is less than 12 hours late when you remember, you should take the missed dose. If it is more than 12 hours late you should just leave out the forgotten dose and take your next dose as usual at your usual time. Don't take a double dose to make up for a missed dose.

Important information about Kliovance

This medicine will not usually cause a monthly menstrual bleed. However, you may experience spotting or breakthrough bleeding during the first few months of treatment. Forgetting or missing a dose may increase the likelihood of breakthrough bleeding. If any bleeding continues after a few months of taking the medicine, or after stopping treatment, you should consult your doctor.

Women taking any form of HRT should have regular medical and gynaecological check-ups. Your need for continued HRT should be reviewed with your doctor at least once a year.

It is important to be aware that all women using HRT have an increased risk of being diagnosed with breast cancer compared with women who don't use HRT. This risk needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. You should discuss these with your doctor before starting HRT. Women on HRT should have regular breast examinations and mammograms and should examine their own breasts regularly. Report any changes in your breasts to your doctor or nurse.

It is important to be aware that women using HRT have a slightly increased risk of stroke and of blood clots forming in the veins (eg deep vein thrombosis/pulmonary embolism) compared with women who don't use HRT. The risk is higher if you have existing risk factors (eg personal or family history of blood clots, smoking, obesity, certain blood disorders - see cautions below) and needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. Discuss these with your doctor before starting treatment.

The risk of blood clots forming in the veins (thromboembolism) while taking HRT may be temporarily increased if you experience major trauma, have surgery, or are immobile for prolonged periods of time (this includes travelling for over three hours). For this reason, your doctor may recommend that you stop taking HRT for a period of time (usually four to six weeks) prior to any planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs, or if you are to be immobile for long periods. The risk of blood clots during long journeys may be reduced by appropriate exercise during the journey and possibly by wearing elastic hosiery. Discuss this with your doctor.

Stop taking this medicine and inform your doctor immediately if you experience any of the following symptoms: stabbing pains or swelling in one leg; pain on breathing or coughing; coughing up blood; breathlessness; sudden chest pain; sudden numbness affecting one side or part of the body; fainting; worsening of epilepsy; migraine or severe headaches; visual disturbances; severe abdominal complaints; increased blood pressure; itching of the whole body; yellowing of the skin or eyes (jaundice); or severe depression.

A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If a potentially fertile women is taking HRT but also requires contraception, a non-hormonal method (eg condoms or contraceptive foam) should be used.

Kliovance should be used with caution by

Women with a risk of developing cancers that are stimulated by oestrogen, for example women whose mother or sister has had breast cancer.

Women with a history of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of hormone preparations such as contraceptive pills (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking HRT.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used by women who are pregnant or breastfeeding. You should stop taking this medicine and consult your doctor immediately if you think you could be pregnant during treatment.

A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If you could get pregnant while taking this HRT, you should use a non-hormonal method of contraception (eg condoms or contraceptive foam). Seek further medical advice from your doctor.

Possible side effects of Kliovance

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the important information section above. Just because a side effect is stated here, it does not mean that all women using this medicine will experience that or any side effect.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

How can Kliovance affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

The following medicines may potentially reduce the blood level and effect of this medicine, which could cause irregular menstrual bleeding or your symptoms to come back:

aprepitant

bosentan

barbiturates

carbamazepine

cobicistat

crizotinib

dabrafenib

efavirenz

eslicarbazepine

fosaprepitant

fosphenytoin

modafinil

nevirapine

oxcarbazepine

phenobarbital

phenytoin

primidone

rifabutin

rifampicin

ritonavir

rufinamide

telaprevir

the herbal remedy St John's wort (Hypericum perforatum)

topiramate

vemurafenib.

Some women with diabetes may need small adjustments in their dose of insulin or antidiabetic tablets while taking this medicine. You should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this medicine.

This medicine may oppose the effect of medicines used to lower high blood pressure. Your blood pressure will usually be checked periodically while you are taking HRT, but this is particularly important if you are also taking medicines for high blood pressure.

This medicine may also oppose the fluid-losing effect of diuretic medicines.

This medicine may decrease the amount of the antiepileptic medicine lamotrigine in the blood. As this could increase the risk of seizures coming back or getting worse, the medicine may not be recommended for women who take lamotrigine on its own for epilepsy.

This medicine may increase the blood levels of the following medicines and this could possibly increase the risk of their side effects:

The materials in this web site are in no way intended to replace the professional medical care, advice, diagnosis or treatment of a doctor. The web site does not have answers to all problems. Answers to specific problems may not apply to everyone. If you notice medical symptoms or feel ill, you should consult your doctor - for further information see our Terms and conditions.

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